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FERVENT-1NCT06421636

A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 21 versions: 21 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 95 → 19 participants
    • Primary and study completion moved earlier from Jan 24, 2028 to Dec 3, 2026
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 26 of 26 sites
    v21
  2. Study sites: 25 to 26v20
  3. Site details revised at 1 of 25 sitesv19
  4. Study sites: 24 to 25v18
  5. Study sites: 22 to 24v17
Show 15 earlier versionsHide 15 earlier versions
  1. Site details revised at 1 of 22 sitesv16
  2. Study sites: 21 to 22v15
  3. Primary endpoints revised (3)
    • Eligibility criteria expanded, about 2 words
    • Secondary endpoints revised (13)
    • Site details revised at 1 of 21 sites
    v14
  4. Study sites: 19 to 21v13
  5. Study sites: 15 to 19v12
  6. Study sites: 13 to 15v11
  7. Study sites: 11 to 13v10
  8. Study sites: 9 to 11v9
  9. Site details revised at 1 of 9 sitesv8
  10. Study sites: 6 to 9v7
  11. Study sites: 5 to 6v6
  12. Study sites: 2 to 5v5
  13. Study sites: 1 to 2v4
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 25, 2024 to Sep 30, 2024
    v3
  15. Eligibility criteria expanded, about 10 wordsv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in Liver Iron Concentration (LIC) by R2* Magnetic Resonance Imaging (MRI)
Timeframe: At week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to week 72
Severity of TEAEs
Timeframe: Up to week 72

Secondary (12)

Achievement of ≥20% reduction from baseline in LIC by R2* MRI
Change from baseline in hemoglobin
Change from baseline in LIC by R2* MRI
Percent change from baseline in LIC by R2* MRI
Change in hemoglobin over time
Show 7 moreShow less
Achievement of ≥1.5 g/dL increase in hemoglobin for two consecutive assessments in the absence of Red Blood Cell (RBC) transfusions
Number of RBC transfusions required
Achievement of transfusion independence
Change in RBC counts over time
Concentrations of REGN7999 in serum over time
Incidence of Anti-Drug Antibody (ADA) to REGN7999 over time
Magnitude of ADA to REGN7999 over time

Arms and interventions

Part A High DoseExperimental

Randomized 2:2:1

Part A Low DoseExperimental

Randomized 2:2:1

Part A PlaceboPlacebo comparator

Randomized 2:2:1

Part B High DoseExperimental

Randomized 2:2:1

Part B Low DoseExperimental

Randomized 2:2:1

Part B PlaceboPlacebo comparator

Randomized 2:2:1

Drugs: REGN7999, Placebo

Sites

26 sites in 9 countries

India 7, Thailand 5, Malaysia 4, Greece 3, Georgia 2, United Kingdom 2, Italy 1, Turkey (Türkiye) 1, United States 1